SUPERSMILE- sodium monofluorophosphate paste, dentifrice

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Robell Research, Inc.
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity toothpaste Aids in the prevention of dental cavities.
Authorization status:
OTC monograph final
Authorization number:
53567-0748-1, 53567-0748-2, 53567-0748-3

SUPERSMILE- sodium monofluorophosphate paste, dentifrice

Robell Research, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Supersmile Rosewater

Active ingredient:

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpos e:

Anticavity toothpaste

Us es :

Aids in the prevention of dental cavities.

Warnings :

As with all fluoride toothpastes, keep out of reach of children under 6 years old. If you accidentally

swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Warnings :

As with all fluoride toothpastes, keep out of reach of children under 6 years old. If you accidentally

swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Directions :

For the best results: Brush teeth thoroughly after each meal at least twice a day, or as directed by a

dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing.

Supervise children as necessary until capable of using without supervision. For children under two

years of age, consult a dentist or a doctor before use.

Inactive ingredients:

Water, Sorbitol, Dicalcium Phosphate Dihydrate, Calcium Carbonate, Sodium Bicarbonate, Titanium

Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Corn Starch, Flavor, Magnesium Carbonate,

Sodium Lauryl Sulfoacetate, Sodium Saccharin

Principal Display Panel

Supersmile®

ROSEWATER MINT

professional

whitening

toothpaste

powered by Calprox®

with fluoride.

Net wt. 4.2 oz / 119 g

SUPERSMILE

sodium monofluorophosphate paste, dentifrice

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5356 7-0 748

Route of Administration

DENTAL, ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -

UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

1.4 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

SO DIUM PERBO RATE TETRAHYDRATE (UNII: 8 22HSQ6 55R)

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA)

CALCIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ9 7GEP)

WATER (UNII: 0 59 QF0 KO0 R)

CALCIUM PERO XIDE (UNII: 7FRO2ENO9 1)

SO RBITO L (UNII: 50 6 T6 0 A25R)

CALCIUM CARBO NATE (UNII: H0 G9 379 FGK)

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM LAURYL SULFO ACETATE (UNII: D0 Y70 F2B9 J)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

MINT (Ro sewater Mint)

Imprint Code

Robell Research, Inc.

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5356 7-0 748 -2

1 in 1 BOX

0 5/0 1/20 17

1

119 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:5356 7-0 748 -3

227 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/0 6 /20 18

3

NDC:5356 7-0 748 -1

40 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 3/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 5/0 1/20 17

Labeler -

Robell Research, Inc. (155571656)

Revised: 8/2020

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